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510(k) K251710

Mobile X-ray unit (!M1) by Solutions For Tomorrow AB — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2025
Date Received
June 3, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mobile
Device Class
Class II
Regulation Number
892.1720
Review Panel
RA
Submission Type

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